Start of mission
November 18, 2019
Job city
Marseille (13008)
Type of contract
CDI

Description

Role within the organisation
Job Title Associate Director, Regulatory Affairs
Division Clinical Development
Team Regulatory Affairs
Location Marseille, France

 Overall Objectives and Purpose of the role
In the Clinical Development Department, reporting to the Senior Director Regulatory Affairs, you will be a core team member within a matrix organization.
 
You will be responsible for providing specific regulatory affairs leadership and support for a new biological product at the stage of registration in Europe and in Switzerland. You will also responsible for the maintenance of the MA (lifecycle management including variations / amendments, renewals, line extensions...). Note that these activities are managed at the global level.

Within the regulatory team, your main mission and responsibilities are the following:
 
 
 

Profile

Main responsibilities and key tasks
Key Tasks:
  • Coordination of an EU centralized Marketing Authorisation Application (MAA) procedure and Swiss MAA under the responsibility of the Senior Director, Regulatory Affairs and in collaboration with an external partner.
  • Maintenance of the Marketing Authorisation (MA) (annual re-assessment, variations,).
  • Revision of approval documents and text management (labeling management) including tracking of updates and implementation.
  • Validation of packaging artworks, labels to ensure compliance to applicable regulations.
  • Participation in the review/validation process for promotional documents and educational documents according to current internal procedures and applicable regulations.
  • Participation in Transparency and Economic dossiers for reimbursement request and prices request.
  • Maintaining/developing knowledge of global competitive landscape, regulatory environment, and regulations.
  • Managing the regulatory Contract Research Organisations (CROs) for coordination and preparation of submissions, if applicable.
  • Functional oversight of regulatory affairs managers in the European structure (internal or external; Business unit or national entities).
 
Experience and Qualifications
Essential:
  • A university degree in biomedical sciences, preferably at Pharm. D or PhD level.
  • 5-8 years' pharma industry experience in regulatory affairs with 3-5 years' experience in the submission and approval of EU oncology products.
  • Extensive knowledge of preparing applications and the handling of centralized procedures in the EU and application procedures in Switzerland.
  • At least 3 years of experience in Regulatory Affairs, ideally for an ‘exploitant' Company.
Desirable:
  • Strong working knowledge and understanding of biologics (mAbs) compounds is highly desired.










 
 
Competencies, Skills and Behaviours
Technical Competencies Additional Skills/ Behaviours
Essential:
  • Hands-on experience in coordinating MAA submissions, and authorities' interactions through approval.
  • Experience and knowledge in the preparation of major regulatory submissions.
  • Experience in leading and providing regulatory input to cross functional project teams.
  • Knowledge of current pharmaceutical and regulatory requirements in the EU and in Switzerland.
  • Sound understanding of the regulatory and quality issues related to an 'exploitant' company.
  • Understanding of the Good Clinical Practice (GCP) regulations, ICH guidelines, Clinical Trial Regulation (CTR) and internal SOPs.


 
Essential:
  • Strong ability to work independently as well as in a team matrix organization with little or no supervision, interacting with several stakeholders (internal and external) and building meaningful relationships at all levels.
  • Excellent communication skills, both verbal and written.
  • Detail oriented with accuracy, clarity and unambiguous.
  • Ability to be flexible (multi-task) and adapt to different situations quickly.
  • Problem solving capabilities - able to seek solutions and identify efficiencies.
  • The applicant must be able to read, write and speak French and English (multi-lingual an advantage).